WO2013177527A1 - Systèmes et procédés de mesure d'écoulement de fluide - Google Patents

Systèmes et procédés de mesure d'écoulement de fluide Download PDF

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Publication number
WO2013177527A1
WO2013177527A1 PCT/US2013/042676 US2013042676W WO2013177527A1 WO 2013177527 A1 WO2013177527 A1 WO 2013177527A1 US 2013042676 W US2013042676 W US 2013042676W WO 2013177527 A1 WO2013177527 A1 WO 2013177527A1
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WIPO (PCT)
Prior art keywords
vessel
speckle density
fluid
elapsed time
speckle
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PCT/US2013/042676
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English (en)
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WO2013177527A8 (fr
Inventor
Sidney Donald NYSTROM
Edward R. Miller
Robert F. Wilson
Kendall R. Waters
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Acist Medical Systems, Inc.
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Publication date
Application filed by Acist Medical Systems, Inc. filed Critical Acist Medical Systems, Inc.
Priority to CN201380027253.1A priority Critical patent/CN104379065B/zh
Priority to EP13728604.3A priority patent/EP2854649B1/fr
Priority to JP2015514223A priority patent/JP6251250B2/ja
Publication of WO2013177527A1 publication Critical patent/WO2013177527A1/fr
Publication of WO2013177527A8 publication Critical patent/WO2013177527A8/fr
Priority to HK15109507.0A priority patent/HK1208791A1/xx

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/12—Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/0205—Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0062—Arrangements for scanning
    • A61B5/0066—Optical coherence imaging
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0082—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes
    • A61B5/0084—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes for introduction into the body, e.g. by catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/026—Measuring blood flow
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/026—Measuring blood flow
    • A61B5/0261—Measuring blood flow using optical means, e.g. infrared light
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/026—Measuring blood flow
    • A61B5/0265—Measuring blood flow using electromagnetic means, e.g. electromagnetic flowmeter
    • A61B5/027—Measuring blood flow using electromagnetic means, e.g. electromagnetic flowmeter using catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/026—Measuring blood flow
    • A61B5/0275—Measuring blood flow using tracers, e.g. dye dilution
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/107—Measuring physical dimensions, e.g. size of the entire body or parts thereof
    • A61B5/1076—Measuring physical dimensions, e.g. size of the entire body or parts thereof for measuring dimensions inside body cavities, e.g. using catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/06—Measuring blood flow
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4444—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to the probe
    • A61B8/445—Details of catheter construction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/52—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/5215—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves involving processing of medical diagnostic data
    • A61B8/5223—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves involving processing of medical diagnostic data for extracting a diagnostic or physiological parameter from medical diagnostic data
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/007—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests for contrast media
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16831—Monitoring, detecting, signalling or eliminating infusion flow anomalies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3375—Acoustical, e.g. ultrasonic, measuring means

Definitions

  • Diagnostic value is attributed to understanding the fluid flow within a patient's vasculature as it may help identify and locate blockages in a vessel of the patient.
  • Thermodilution is one method that may be used to determine fluid flow through a vessel of a patient and is commonly performed using a Swan-Ganz catheter, also known as a pulmonary artery catheter, which is used exclusively in the heart.
  • Thermodilution determines cardiac output of the heart by introducing a heated or cooled fluid into the heart and then measuring a change in temperature downstream. A cardiac output is determined based on the measured change in temperature.
  • Other methods for determining fluid flow within a vessel include Doppler techniques, which use ultrasound and the Doppler effect to determine velocity of blood through a vessel. Doppler techniques, however, are susceptible to error induced by backflow or other turbulent velocity fluctuations that may occur in a vasculature of a patient.
  • Fluid flow through a vessel may also be estimated using fractional flow reserve (FFR) techniques.
  • FFR techniques typically estimate fluid flow by measuring pressure across a lesion in a vessel.
  • FFR techniques do not measure fluid flow through the vessel, but rather approximate/estimate the flow rate as FFR measurements are performed during hyperemia (e.g., drug induced dilation of the blood vessels).
  • IVUS involves one or more ultrasound transducers emitting ultrasound energy based on received electrical signals and sending return electrical signals based on ultrasound energy reflected by various intravascular structures.
  • IVUS is often used to generate images.
  • a console with a high-resolution display is able to display IVUS images in realtime.
  • IVUS can be used to provide in-vivo visualization of the vascular structures and lumens, including the coronary artery lumen, coronary artery wall morphology, and devices, such as stents, at or near the surface of the coronary artery wall.
  • IVUS imaging may be used to visualize diseased vessels, including coronary artery disease.
  • the ultrasound transducer(s) can operate at a relatively high frequency (e.g., 10 MHz-60 MHz, in some preferred embodiments, 40 MHz-60 MHz) and can be carried near a distal end of an IVUS catheter.
  • a relatively high frequency e.g. 10 MHz-60 MHz, in some preferred embodiments, 40 MHz-60 MHz
  • Some IVUS systems involve mechanically rotating the IVUS catheter for 360-degree visualization.
  • imaging systems may include an injection system configured to deliver a flushing agent into the vessel before the vessel is imaged.
  • This disclosure generally relates to systems and methods that may be used to measure fluid flow through a vessel using imaging techniques.
  • a measurement system employing intravascular ultrasound (IVUS), optical coherence tomography (OCT), or other suitable imaging technique may be used to determine fluid flow through a vessel.
  • IVUS intravascular ultrasound
  • OCT optical coherence tomography
  • an injector system of a measurement system may deliver a bolus of a flushing agent into a vessel of a patient and the bolus may be observed using, for example, an ultrasound transducer. Data collected from the ultrasound transducer may be used to determine a travel distance of the bolus within the vessel and/or an elapsed time during which the bolus traveled the distance.
  • the flow rate of the vessel may then be determined based on the travel distance and the elapsed time during which the bolus traveled.
  • the travel distance may be derived where a cross-sectional area of the vessel and the volume of the bolus are known or calculated.
  • Examples disclosed in this disclosure may provide one or more advantages over existing systems and methods to determine flow rate within a vasculature of a patient.
  • fluid flow may be measured in any vessel large enough to accommodate an imaging catheter (e.g., an IVUS or OCT catheter).
  • some examples actually measure fluid flow by observing a rate of travel of a bolus in a vessel as compared to systems and methods that provide an approximation or prediction of fluid flow.
  • fluid flow measurements in some examples may be performed using commercially available imaging systems providing the advantage of performing fluid flow measurements during intravascular imaging operations as compared to non-procedure related methods to measure and calculate fluid flow.
  • the ability to measure fluid flow during an imaging operation decreases diagnosis time as potential issues requiring fluid flow measurements may be immediately performed without having to schedule another procedure or using additional equipment. Accordingly, cost savings and time savings may be enjoyed by patients and care providers.
  • FIG. 1 is an illustrative system configured to perform hemodynamic measurements.
  • FIG. 2 is a block diagram of an illustrative IVUS system configured to perform hemodynamic measurements.
  • FIG. 3A is a side cross-sectional view of an illustrative catheter assembly that may be used in the IVUS system of FIG. 2.
  • FIG. 3B is a side cross-sectional view of a distal section of an illustrative catheter assembly.
  • FIG. 4 is a flow diagram illustrating a method for determining a flow rate through a vessel of a patient.
  • FIGS. 5A-5C are cross-sectional views of a catheter assembly within a vessel of a patient.
  • FIG. 6 is a plot of speckle density generated by a measurement engine over time.
  • FIG. 7A illustrates a technique for manually clearing blood from a vessel for imaging.
  • FIG. 7B illustrates a technique for automatically clearing blood from a vessel for imaging.
  • FIG. 1 is an illustrative example of a system 100 that may be configured to perform hemodynamic measurements, for example fluid flow within a vasculature of a patient.
  • System 100 may include a catheter assembly 102 having a proximal end 104 and a distal end 106 configured to be inserted into a vessel of a patient 144.
  • catheter assembly 102 may be inserted into patient 144 via the femoral artery and guided to an area of interest within the patient 144.
  • the broken lines in FIG. 1 represent portions of catheter assembly 102 within the patient 144.
  • catheter assembly 102 may include an intravascular measuring device 108 having a measurement module within distal end 106 configured to emit and receive wave-based energy and generate measurement data— e.g., to image the area of interest within the patient 144.
  • intravascular measuring device 108 may comprise an IVUS imaging probe including an ultrasound transducer configured to emit and receive ultrasound sound energy and generate ultrasound data.
  • system 100 may be an OCT system wherein the intravascular measuring device may comprise an OCT imaging probe including a measurement module configured to emit and receive light and generate OCT data.
  • System 100 may include a translation mechanism 1 19, which may comprise a patient interface module (PIM) 120 and a linear translation system (LTS) 122.
  • LTS 122 may be mechanically engaged with catheter assembly 102 and configured to translate the catheter assembly 102 a controlled distance within the patient 144 during a translation operation, for example a pullback or push- forward operation.
  • PIM 120 of the translation mechanism 1 19 can act as an interface with the catheter assembly 102.
  • a computing machine 140 of system 100 may comprise one or more processors configured to receive commands from a system user 142 and/or display data acquired from catheter assembly 102 via a user interface.
  • the computing machine may be a personal computer including computer peripherals (e.g., keyboard, mouse, electronic display) to receive inputs from the system user 142 and output system information and/or signals received from catheter assembly 102 (e.g., rendered images).
  • the user interface of the computing machine may be a touchscreen display configured to act as both an input device and an output device.
  • computing machine 140 may include memory modules for storing instructions, or software, executable by the one or more processors.
  • computing machine 140 may include software such that the computing machine 140 operates as a measurement engine for measuring fluid flow within the vasculature of a patient.
  • FIG. 2 is a high-level block diagram of an example of an IVUS system 200 that may be used to perform hemodynamic measurements.
  • IVUS system 200 can include a measurement engine 210, a PIM 230, a LTS 220, and a catheter assembly 240.
  • Measurement engine 210 can be the central component of the IVUS system 200 and may perform one or more functions including, for example, hemodynamic calculations, image generation, display of IVUS images and other information, control of the system components, storing and exporting the image data, a user interface (e.g., GUI) for operating the system, analysis tools (e.g., area measurements, linear measurements, and annotations), and so on.
  • measurement engine may be a computing machine comprising one or more programmable processors.
  • measurement engine may comprise one or more memory modules including instructions that may be executed by one or more programmable processors (e.g., software).
  • PIM 230 can provide the electromechanical interface between catheter assembly 240 and measurement engine 210.
  • PIM 230 can provide the mechanical interface to secure catheter assembly 240, as well as the mechanical energy to rotate an imaging assembly of catheter assembly 240.
  • PIM 230 can provide the electrical interface that transmits signals from an integrated ultrasound generator to catheter assembly 240 and receives return signals.
  • the catheter assembly 240 may be a minimally invasive intravascular ultrasound imaging catheter.
  • the catheter assembly 240 can emit ultrasound energy from a transducer at its distal tip, which may be guided into an area of interest of a patient, for example the coronary arteries of the heart. Ultrasound waves that are reflected from vascular tissues can be received by the transducer and sent through PIM 230 to measurement engine 210.
  • the catheter assembly 240 may be operated at selected frequencies, such as 40 MHz or 60 MHz, depending on user preference or a specific application.
  • catheter assembly 240 can include a drive cable surrounded by a sheath.
  • the proximal end of catheter assembly 240 can connect to PIM 230 and can be mechanically rotated by PIM 230.
  • the distal end of catheter assembly 240 may include an intravascular measuring device having an imaging element connected to and rotated through 360 degrees by the drive cable.
  • the imaging element may be a broadband ultrasound transducer that emits and receives ultrasound energy between, for example, 40 MHz and 60 MHz depending on the user-selectable settings. It can be appreciated that the frequency at which the ultrasound transducer emits and receives acoustic energy may vary based on the application.
  • Some drive cables contain an electrical transmission line that electrically connects PIM 230 to the ultrasound transducer.
  • the imaging element can continuously scan (rotate) through 360 degrees.
  • PIM 230 can send an electrical signal (e.g., high frequency pulse) through the transmission line to the ultrasound transducer.
  • this high frequency pulse can be periodically and continuously sent to the transducer to excite the transducer.
  • the transducer can convert the electrical signal into an ultrasound energy pulse or pressure wave.
  • the pressure wave is transmitted through an elongated imaging window of the catheter and into the adjacent vascular tissues.
  • the vascular tissues can interact with and reflect the pressure wave back through the imaging window and onto the transducer.
  • the transducer can convert the received ultrasound energy back into electrical energy.
  • the electrical energy can then be transmitted, via the transmission line embedded in the drive cable, back to PIM 230 and then back to the measurement engine 210 for hemodynamic measurement.
  • Some examples include a telescope assembly integrated into the catheter assembly that allows the imaging of multiple regions of interest in a single procedure by advancing or retracting the imaging assembly without moving the catheter sheath.
  • the transducer can be longitudinally translated along the imaging window by extending and collapsing the telescope assembly. This system allows for imaging along a length of an artery without moving the catheter sheath.
  • the longitudinal translation can be performed manually by the system user or under motorized control. Motorized longitudinal translation enables the acquisition of calibrated three-dimensional volume data. This allows the measurement engine 210 to accurately measure distances along the length of the artery under investigation.
  • the longitudinal translation is provided by a Linear Translation System (LTS) 220 that mates with PIM 230 and catheter assembly 240 to enable pullback of the imaging element at a controlled rate.
  • LTS 220 can provide calibrated linear translation for measurements on the longitudinal image.
  • LTS 220 may feature a display, which indicates the linear distance traversed and the pullback speed, as well as controls for starting/stopping pullback, setting pullback speed, resetting linear distance traversed to zero, and switching to manual mode. In manual mode, the system user can freely move the catheter imaging element forward and backward.
  • the LTS 220 may be configured to enable either pullback and/or push- forward of the catheter imaging element at a controlled rate.
  • the LTS 220 may be configured to oscillate the catheter imaging element by alternately performing pullback and push-forward operations.
  • IVUS system 200 may also include an injection system 250 configured to deliver fluid into a vessel of a patient.
  • the injection system 250 may comprise an automated injector pump configured to deliver one or more fluids (e.g., contrast or saline) into the patient.
  • the automated injector pump may be in electrical communication with, and controlled by, measurement engine 210.
  • injection system 250 may comprise a controller configured to control the automated injector pump.
  • the injection system 250 may be a manual injection pump (e.g., syringe injection) configured to allow a user to manually deliver one or more fluids into the patient.
  • the injection system 250 may be in fluid communication with catheter assembly 240 such that fluid from the injection system is delivered into a patient's vasculature via the catheter assembly 240.
  • the injection system 250 may be configured to deliver any number of fluids and any quantity of fluid as appropriate for a specific application of IVUS system 200.
  • FIG. 3A is a side cross-sectional view of a catheter assembly 300 that may be used in IVUS system 200 of FIG. 2.
  • a drive cable 304 may be mechanically engaged and electrically connected to a PIM (not shown) via a connector 302. Accordingly, the PIM may be used to rotate the drive cable within sheath 303.
  • An intravascular measuring device 309 including an ultrasound transducer 308 may be located in a distal section 330 of the catheter assembly 300.
  • the intravascular measuring device 309 may be coupled to the drive cable such that rotation of the drive cable also causes the ultrasound transducer 308 to rotate within sheath 303.
  • the ultrasound transducer 308 may be configured to emit and receive ultrasound energy and generate ultrasound data.
  • catheter assembly 300 may include an imaging window 306 substantially transparent to the frequency of the ultrasound energy emitted by ultrasound transducer 308.
  • catheter assembly 300 may be in fluid communication with an injection system to deliver a quantity of fluid, or a bolus of fluid, from the injection system to a vessel of a patient.
  • catheter assembly 300 can include an injection cannula 342 in fluid communication with the injection system upstream of point 340.
  • the injection cannula 342 can include an injection cannula lumen 344 and an injection port 346 for delivering the fluid into the vessel.
  • the injection system may deliver small boluses of fluid (e.g., saline or contrast dye) into the injection cannula lumen 344, out the injection port 346 and into the vessel.
  • the injection port 346 may be located in a proximal section 320 of the catheter assembly upstream of ultrasound transducer 308 such that the injected bolus will travel with the blood flow within the vessel (i.e., left to right with reference to FIG. 3 A) towards the ultrasound transducer 308.
  • the bolus may comprise fluid that is substantially transparent to the wavelength emitted by the ultrasound transducer 308 and used as a flushing agent to clear the vessel of blood to allow for imaging of the vessel.
  • FIG. 3B is a side cross-sectional view of a distal section 350 of a catheter assembly.
  • distal section 350 may be used in lieu of distal section 330 included in catheter assembly 300 of FIG. 3A.
  • Distal section 350 is similar to distal section 330 of catheter assembly 300 except that distal section 350 can include a short monorail guidewire system 351.
  • the monorail guidewire system may include a distal end 352 forming a guidewire lumen 356 configured to accept a guidewire 354 to guide a catheter assembly into a vascular system of a patient. It can be appreciated that different examples may be configured to accept different guidewires depending on the application of the catheter assembly.
  • the catheter may be a 6F guide catheter compatible device, and the guidewire engagement system may be compatible with commercially available 0.014 in guidewires.
  • the monorail may include a distal radiopaque marker (not shown) in distal section 350.
  • the radiopaque marker may be located in distal end 352.
  • the distal radiopaque marker may be located 8 mm from the distal end of the catheter.
  • the catheter's distal tip entry profile may be ⁇ 2.0F
  • the catheter's crossing profile may be 3.2F
  • the catheter's working length may be 142 cm.
  • FIG. 4 is a flow diagram illustrating a method 400 for determining a flow rate through a vessel of a patient.
  • method 400 may be configured to determine a velocity of blood and/or a volumetric flow rate through the vessel.
  • Method 400 of FIG. 4 may be implemented in full or in part by a measurement engine of a measurement system.
  • the measurement system may be an IVUS system similar to IVUS system 200 of FIG. 2.
  • method 400 can include delivering 410 a quantity of fluid into a vessel of a patient, generating 420 data while the quantity of fluid is in the vessel, determining 430 a travel distance of the quantity of fluid, determining 440 an elapsed time based on the data, and calculating a flow rate based on the travel distance and the elapsed time.
  • the flow rate measured is volumetric flow
  • method 400 may be configured to determine 444 a physical dimension of the vessel before calculating 450 the volumetric flow rate.
  • an injector system may deliver a bolus of fluid 410 into a vessel of a patient and an intravascular measurement device may be used to generate data 420 while the bolus is in the vessel.
  • a travel distance of the bolus within the vessel may be known or the data generated 420 may be used to determine the travel distance 430.
  • the data generated 420 may also be used to determine an elapsed time 440 during which the bolus traveled the distance.
  • a flow rate of the vessel may then be calculated 450 based on the travel distance and the elapsed time. In examples where the flow rate is a velocity of fluid in the vessel, the flow rate may be calculated 450 using the following equation:
  • velocity v may be calculated 450 by dividing the travel distance of the bolus within the vessel D by the elapsed time ⁇ T during which the bolus traveled the distance.
  • the travel distance may be determined 430 based on a physical dimension of the vessel and a known volume of the quantity of fluid using the following equation:
  • travel distance D may be determined by dividing the volume of the quantity of fluid Vol by a physical dimension .4 of the vessel.
  • the physical dimension may be a cross-sectional area of the vessel.
  • dividing the volume of the quantity of fluid by the cross-sectional area of the vessel may produce a longitudinal dimension, or a length, of the quantity of fluid.
  • the length of the quantity of fluid may be the travel distance D per the flow rate equation referenced above.
  • the measurement engine may be configured to automatically determine the physical dimension and the volume of the quantity of fluid and calculate travel distance D.
  • velocity of fluid in the vessel may be determined based on the volume of the quantity of fluid Vol, the physical dimension of the vessel A, and the elapsed time ⁇ T using the following equation:
  • the intravascular measurement device may be used to determine 444 a cross-sectional area of the vessel and the flow rate may be calculated 450 by multiplying the cross-sectional area by a velocity of fluid in the vessel.
  • a measurement engine may be configured to determine a start time and/or an end time based on generated data 420 to calculate an elapsed time.
  • a measurement engine employing ultrasound technology may be configured to generate a speckle density of fluid within the vessel to determine 440 an elapsed time during which the bolus traveled the travel distance.
  • the speckle density may be used to detect a position of the quantity of fluid within the vessel to determine a start time and/or an end time. Speckle is an image artifact that commonly appears as specks in ultrasound images that are caused when structure in an object is on a scale too small to be resolved by an imaging system.
  • a density of speckle (e.g., the density of specks in the ultrasound image) is directly correlated to the concentration of unresolvable structure in an object.
  • Blood may be a cause of speckle in an ultrasound image as the content of blood (e.g., red blood cells, white blood cells, platelets) is too small to be resolved by an ultrasound transducer.
  • speckle is considered an undesirable image artifact as it can mask small but potentially diagnostically significant imaging features.
  • many imaging systems e.g., IVUS, OCT
  • a flushing agent e.g., saline, contrast, Ringer's solution, dextran, lactate solution
  • the flushing agent may be a fluid that is substantially transparent to the wavelength emitted by the ultrasound transducer.
  • a measurement engine may be configured to detect the position of a bolus comprising a flushing agent within a vessel based on a detection of speckle in the ultrasound data.
  • the measurement engine is configured to generate a speckle density
  • a leading edge of the bolus may be detected when the speckle density goes from high (e.g., speckle caused by blood) to low (e.g., absence of speckle in the flushing agent).
  • a trailing edge of the bolus may be detected when the speckle density goes from low (e.g., flushing agent) to high (e.g., blood).
  • one or more speckle density thresholds may be used to determine a start and/or end time corresponding to a moment where the leading or trailing edge of the bolus is detected by the ultrasound transducer.
  • the speckle density threshold may be predetermined and/or selected by a user.
  • the measurement engine may be configured to automatically determine a speckle density based on a configuration of the system and/or the specific imaging conditions of the application.
  • Similar methods may be used to determine the position of a bolus using imaging technologies other than IVUS.
  • the methods described above may be adapted for a measurement engine employing OCT technologies.
  • the bolus may comprise an optically transparent flushing agent.
  • the OCT may detect optical transparency in the vessel to determine the position of the bolus. Accordingly, in some examples, optical transparency thresholds may be used to detect the position of the bolus.
  • FIGS. 5A-5C are cross-sectional views of a catheter assembly 500 within a vessel 520 of a patient.
  • catheter assembly 500 may include an injection port 502 and an intravascular measurement device 503 including an ultrasound transducer 504.
  • Catheter assembly 500 may be configured to deliver a bolus of fluid into vessel 520 via injection port 502.
  • the bolus of fluid may comprise a flushing agent.
  • FIGS. 5A, 5B and 5C illustrates positions of a bolus of fluid 530 within vessel 520 during and after the injection of the bolus 530 over sequential time points A, B and C, respectively.
  • FIG. 5A corresponds with time point A, wherein bolus 530 is initially injected into vessel 520. After time point A, bolus 530 is forced by blood flow 522 towards ultrasound transducer 504.
  • FIG. 5B corresponds with time point B, wherein a leading edge 532 of bolus 530 reaches ultrasound transducer 504. After time point C, bolus 530 continues to be forced by blood flow 522 across ultrasound transducer 504.
  • FIG. 5C corresponds with time point C wherein a trailing edge 534 of bolus 530 reaches the ultrasound transducer.
  • a flow rate through a vessel may be calculated between time points A and B, between time points A and C, and/or between time points B and C.
  • method 400 of FIG. 4 may be used to determine fluid flow through a vessel between time points A and B.
  • the bolus of fluid 530 may be delivered 410 into vessel 520 via injection port 502 of catheter assembly 500.
  • Intravascular measurement device 503 may then image the vessel and generate 420 ultrasound data that may be received by the measurement engine.
  • the measurement engine may be configured to determine 430 a travel distance 550 between injection port 502 and ultrasound transducer 504.
  • travel distance 550 may be predetermined where catheter assembly 500 is configured such that the distance between the injection port and the ultrasound transducer is fixed.
  • the distance between injection port 502 and ultrasound transducer 504 may vary where the catheter assembly is configured for linear translation (i.e., pullback and push forward operations).
  • the measurement engine may be configured to determine travel distance 550 by communicating with the linear translation system to acquire and/or calculate a physical position of the ultrasound transducer relative to the injection port.
  • the measurement engine may be configured to determine 440 an elapsed time during which the bolus 530 travels the travel distance 550. As noted above, the elapsed time may be calculated by determining a start time and an end time. In this example, the start time corresponds with time point A, wherein the bolus is introduced into the vessel. In examples where the measurement system includes a manual injection system (e.g., syringe), the start time may be determined and recorded by a user of the system. In some examples, the measurement engine may be in communication with the injection system such that when the bolus is delivered, the measurement engine is able to determine a time of injection. In examples where the measurement system includes an automated/synchronized injection system, the measurement engine may be configured to automatically trigger delivery of the bolus and note the time of delivery.
  • a manual injection system e.g., syringe
  • the measurement engine may be in communication with the injection system such that when the bolus is delivered, the measurement engine is able to determine a time of injection.
  • the end time corresponds with time point B, wherein leading edge 532 of the bolus reaches ultrasound transducer 504.
  • the measurement engine may be configured to generate a speckle density based on the generated 420 ultrasound data and identify leading edge 532 of the bolus based on a change in the speckle density generated.
  • ultrasound data generated in FIG. 5A at time point A may be associated with a high speckle density, because ultrasound transducer 504 is surrounded by blood.
  • the ultrasound data generated in FIG. 5B at time B may be associated with a lower speckle density, as ultrasound transducer 504 is surrounded by a fluid comprising a mixture of flushing agent and blood.
  • the leading edge 532 may be detected based on when the generated speckle density crosses a predetermined speckle density threshold from high (e.g., blood) to low (e.g., flushing agent). Accordingly, the end time, or in this example, time point B, is when the speckle density crosses the predetermined speckle density threshold from high to low.
  • the elapsed time may then be determined 440 by calculating the time between the start time and the end time.
  • the flow rate through the vessel between time point A and time point B may then be calculated 450 by dividing the travel distance 550 by the elapsed time.
  • method 400 of FIG. 4 may be used to determine a flow through a vessel between time points B and C.
  • the bolus of fluid 530 may be delivered 410 and data may be generated 420 using steps similar to the steps described above with regard to determining fluid flow between time points A and B.
  • the start time may correspond with time point B wherein leading edge 532 reaches ultrasound transducer 504, and the end time may correspond with time point C wherein trailing edge 534 reaches the ultrasound transducer.
  • leading edge 532 may be detected based on when the generated speckle density crosses a predetermined speckle density threshold from high (e.g., blood) to low (e.g., flushing agent), and the start time may be determined based on when the leading edge is detected.
  • trailing edge 534 may be detected based on when the generated speckle density crosses a predetermined speckle density threshold from low (e.g., flushing agent) to high (e.g., blood), and the end time may be determined based on when the trailing edge is detected.
  • a first predetermined speckle density threshold may be used to determine the start time and a second predetermined speckle density threshold may be used to determine the end time.
  • travel distance 552 corresponds with a longitudinal dimension, or a length, of the bolus of fluid and may be determined 430 based on a physical dimension of the vessel (e.g., cross-sectional area of the vessel) and a known volume of the bolus of fluid.
  • the measurement engine may be configured to calculate a cross-sectional area or a diameter of the vessel. Further, the measurement engine may be configured to automatically determine and/or measure the volume of the bolus injected into the vessel. Travel distance 552 may be determined based on the known volume of the bolus of fluid and the cross-sectional area of the vessel.
  • travel distance 552 can be the volume of the bolus 530 divided by the cross-sectional area of the vessel 520, as that entire length of bolus 530 will have traveled past ultrasound transducer 540 between time point B and time point C. Accordingly, the flow rate through the vessel between time point B and time point C may be calculated 450 by dividing travel distance 552 by the elapsed time. In some instances, the flow rate may be calculated 450 by dividing the known volume of fluid by the product of the cross-sectional area of the vessel and the elapsed time.
  • method 400 of FIG. 4 may be used to determine fluid flow through a vessel between time points A and C.
  • the bolus of fluid 530 may be delivered 410 and data may be generated 420 using steps similar to the steps described above with regard to determining fluid flow between time points A and B, and also time points B and C.
  • Travel distance 554 of bolus 530 is equal to the sum of travel distance 550 and travel distance 552.
  • Travel distance 550 and travel distance 552 may be determined using the steps described above with regard to determining fluid flow between time points A and B, and between time points B and C, respectively.
  • the elapsed time may be determined 440 based on an end time corresponding with time point C wherein trailing edge 534 of bolus 530 reaches ultrasound transducer 504.
  • trailing edge 534 may be detected based on when the generated speckle density crosses a predetermined speckle density threshold from low (e.g., flushing agent) to high (e.g., blood). Accordingly, the end time, or in this example time point C, is when the speckle density crosses the predetermined speckle density threshold from low to high.
  • fluid turbulence and/or recirculation of blood in a vessel may cause variance in the shape of leading edge 532 as compared to trailing edge 534 of the bolus 530 and therefore different predetermined speckle density thresholds may be used depending on whether fluid flow is measured between time points A and B or time points A and C.
  • a measurement engine may be configured to calculate multiple flow rates using one or all of the examples described above. For example, a measurement engine may be configured to calculate the flow rates between time points A and B, A and C, and B and C. The multiple flow rates calculated may be averaged to even out potential error, or compared to eliminate outlying results.
  • FIG. 6 is a plot 600 of speckle density 602 generated by a measurement engine over time.
  • plot 600 includes time points A and B which correspond to FIGS. 5A and 5C, respectively, and time points CI and C2 which correspond with FIG. 5C.
  • Speckle density 602 includes a first portion 604 corresponding to leading edge 532 of bolus 530, and a second portion 606 corresponding to a trailing edge 534 of the bolus.
  • Plot 600 also includes first and second predetermined speckle density thresholds 620 and 622, respectively, which may be used alone or in combination to determine when leading edge 532 and trailing edge 534 reach ultrasound transducer 504.
  • time point A corresponds with an initial injection of bolus of fluid 530 into vessel 520.
  • ultrasound transducer 504 is surrounded by blood, and the speckle density 602 at time point A is high.
  • the speckle density 602 continues to decrease as the leading edge of the bolus 530 nears the ultrasound transducer 504.
  • a measurement engine may determine that the leading edge of the bolus 530 has reached ultrasound transducer 504 at time point B when speckle density 602 crosses first
  • predetermined speckle density threshold 620 from high to low.
  • the measurement engine may determine that trailing edge 534 of bolus 530 has reached the ultrasound transducer at time point CI when speckle density 602 crosses first predetermined speckle density threshold 620 from low to high.
  • a measurement engine may be configured to use more than one predetermined speckle density threshold.
  • a measurement engine may be configured to use first and second predetermined speckle density thresholds 620 and 622 to determine when a leading edge of a bolus and a trailing edge of a bolus have reached the ultrasound transducer 504, respectively. Accordingly, a measurement engine may determine that trailing edge 534 of bolus 530 crosses the ultrasound transducer at time point C2 when speckle density 602 crosses the second predetermined speckle density threshold from low to high.
  • the use of more than one predetermined speckle density thresholds may be advantageous where there is recirculation of blood in the vessel that may cause variance between the leading edge and the trailing edge of the bolus.
  • a measurement system may include a measurement engine in communication with, and/or synchronized to, an injection system.
  • fluid delivered into a vessel of a patient may displace the blood within the vessel.
  • FIG. 7A illustrates a common method for manually clearing blood from an area of interest within a vessel and imaging the area of interest using the measurement engine.
  • the measurement engine may begin scanning.
  • fluid may be manually injected into the vessel to displace the blood within the area of interest.
  • a user may begin imaging the area of interest using the measurement engine in step 708.
  • user delay may cause blood to be displaced from the vessel for longer than necessary to perform the imaging of the area of interest as the user may not immediately begin imaging in step 708 as soon as blood is displaced. Further, the user may not deactivate the manual injection to cease displacement of the blood immediately after the imaging is complete. Consequently, for a period of time 710 before imaging is commenced, and for a period of time 712 after imaging is completed, blood is needlessly displaced from the vessel without providing any benefit to the quality of the image.
  • FIG. 7B illustrates an example where blood displacement is minimized during imaging.
  • a measurement engine may be in communication and/or synchronized with an injection system. As shown in FIG. 7B, the measurement engine may begin scanning in step 732 and fluid may be automatically injected into the vessel in step 734 to displace the blood within the vessel.
  • the measurement engine may be configured to delay imaging. The period of delay may be the length of time it takes for fluid to travel from the injection system to the area of interest. After the delay, the measurement engine may begin imaging the area of interest in step 738. When properly synchronized, the measurement engine will begin imaging immediately after blood is displaced from the vessel.
  • time period 710 wherein blood is displaced and no imaging is taking place, may be substantially reduced.
  • a similar delay may also be used at the tail end of imaging.
  • the injection system may be configured to cease delivery of the fluid in step 740 before the measurement engine ceases imaging. After a predetermined delay, the measurement engine may cease imaging in step 744. When properly synchronized, the measurement engine will cease imaging immediately before blood returns to the area of interest.
  • the measurement engine may be configured to trigger the injection system to automatically deliver the fluid. In some examples, the measurement engine may be configured to communicate to the injection system to stop delivery of the fluid.
  • a start time may be more accurately determined based on synchronization and/or communication between the measurement engine and the injection system as compared to the use of a manual injection system. As blood flow may reach speeds up to 1 meter per second in the vasculature of a patient, any delay in recording the start time may introduce significant error into the fluid flow measurement.
  • a measurement engine may be synchronized with an injection system to automatically disable image filtering functionality during measurement operations. For example, many IVUS imaging systems include filtering functionality to reduce image artifacts caused by speckle in an ultrasound image.
  • Reduction of speckle while advantageous for imaging, reduces the speckle density contrast between that of blood and a flushing agent and may inhibit the detection of the leading and trailing edges of a bolus.
  • higher measurement accuracy may be achieved in a system where the measurement engine is synchronized, and/or in communication, with a the injection system.
  • processors including one or more microprocessors, digital signal processors (DSPs), application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), or any other equivalent integrated or discrete logic circuitry, as well as any combinations of such components.
  • DSPs digital signal processors
  • ASICs application specific integrated circuits
  • FPGAs field programmable gate arrays
  • processors may generally refer to any of the foregoing logic circuitry, alone or in combination with other logic circuitry, or any other equivalent circuitry.
  • a control unit comprising hardware may also perform one or more of the techniques of this disclosure.
  • Such hardware, software, and firmware may be implemented within the same device or within separate devices to support the various operations and functions described in this disclosure.
  • any of the described units, modules or components may be implemented together or separately as discrete but interoperable logic devices. Depiction of different features as modules or units is intended to highlight different functional aspects and does not necessarily imply that such modules or units must be realized by separate hardware or software components. Rather, functionality associated with one or more modules or units may be performed by separate hardware or software components, or integrated within common or separate hardware or software components.
  • the techniques described in this disclosure may also be embodied or encoded in a non-transitory computer-readable medium, such as a computer-readable storage medium, containing instructions.
  • Non-transitory computer readable storage media may include volatile and/or non-volatile memory forms including, e.g., random access memory (RAM), read only memory (ROM), programmable read only memory (PROM), erasable programmable read only memory (EPROM), electronically erasable programmable read only memory (EEPROM), flash memory, a hard disk, a CD-ROM, a floppy disk, a cassette, magnetic media, optical media, or other computer readable media.
  • RAM random access memory
  • ROM read only memory
  • PROM programmable read only memory
  • EPROM erasable programmable read only memory
  • EEPROM electronically erasable programmable read only memory
  • flash memory a hard disk, a CD-ROM, a floppy disk, a cassette, magnetic media, optical media, or other computer readable media.

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Abstract

L'invention concerne des systèmes et des procédés pour mesurer un écoulement de fluide dans un système vasculaire d'un patient. Certains systèmes peuvent comprendre un système d'injection configuré pour injecter un bolus de fluide dans un vaisseau d'un patient. Certains systèmes peuvent comprendre un moteur de mesure configuré pour surveiller le bolus de fluide dans le vaisseau à l'aide de données de mesure générées par un dispositif de mesure intravasculaire. Le moteur de mesure peut déterminer une distance de parcours du bolus de fluide et un temps écoulé pendant lequel le bolus de fluide a traversé la distance de parcours sur la base des données de mesure. Un débit de fluide (par exemple, la vitesse, l'écoulement volumétrique) du vaisseau peut être calculé à l'aide de la distance de parcours et du temps écoulé.
PCT/US2013/042676 2012-05-25 2013-05-24 Systèmes et procédés de mesure d'écoulement de fluide WO2013177527A1 (fr)

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CN201380027253.1A CN104379065B (zh) 2012-05-25 2013-05-24 流体流量测量***和方法
EP13728604.3A EP2854649B1 (fr) 2012-05-25 2013-05-24 Systèmes et procédés de mesure d'écoulement de fluide
JP2015514223A JP6251250B2 (ja) 2012-05-25 2013-05-24 流量計測システム及び方法
HK15109507.0A HK1208791A1 (en) 2012-05-25 2015-09-25 Fluid flow measurement systems and methods

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CN104379065B (zh) 2018-07-13
JP2015517394A (ja) 2015-06-22
JP6251250B2 (ja) 2017-12-20
EP2854649A1 (fr) 2015-04-08
HK1208791A1 (en) 2016-03-18
EP2854649B1 (fr) 2018-07-11
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US20130317359A1 (en) 2013-11-28
WO2013177527A8 (fr) 2014-04-10

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